P4638 - Comparative Efficacy of Mycophenolate Mofetil vs Azathioprine as First-Line Treatments for Autoimmune Hepatitis in Treatment Naive Patients: A Meta-Analysis

Muhammad Tayyab Anwar, MD¹, Muhammad Shahzil, MD², Muhammad Ali Khaqan, MD¹, Edzel Lorraine Co, MD³, Alejandro J. Nieto Dominguez, MD¹, Sibgha Farooq, MBBS⁴, Maryam Kausar Nawaz, MBBS⁵, Rameez Akram Tarar, MD⁶, Hamza Naeem, MD⁶, Muhammad Bilal Ibrahim, MD¹, Anzal Abdullah, ^4
1John H. Stroger, Jr. Hospital of Cook County, Chicago, IL; ²Penn State Health Milton S. Hershey Medical Center, Hershey, PA; ³University of Santo Tomas, Manila, National Capital Region, Philippines; ⁴University of Health Sciences, Lahore, Punjab, Pakistan; ⁵Lahore Medical and Dental College, Lahore, Punjab, Pakistan; ⁶King Edward Medical University, Lahore, Punjab, Pakistan

Introduction: Autoimmune hepatitis (AIH) is a chronic liver disease characterized by elevated serum IgG, autoantibodies, and interface hepatitis, Azathioprine as first-line therapy. However, recent evidence shows that 50% of patients do not achieve a complete biochemical response (CBR) and remain at risk of disease progression. This meta-analysis compares the efficacy of mycophenolate mofetil (MMF) versus azathioprine (AZA) as first-line treatments for autoimmune hepatitis (AIH).

Methods: We searched Randomized control trials (RCTs) upto May 2024 on different databases, including PubMed, Google Scholar, Scopus, Cochrane CENTRAL databases including Embase, BioMed Central, ICTRP, and ClinicalTrials.gov. The studies meeting the inclusion criteria were included. Statistical analyses were conducted with RevMan using a random-effects model, with significance set at p < 0.05.

Results: Four studies with 640 patients, out of 405 screened studies, were selected. MMF group included 392, while the AZA group had 248 patients. Primary outcomes included Complete Biochemical Response (CBR) (OR: 2.89; 95% CI: 0.76, 10.99), which did not show a significant difference, No Response (OR: 0.45; 95% CI: 0.24, 0.85), showed a significant difference, and Relapses during tapering or withdrawal of corticosteroids (OR: 1.08; 95% CI: 0.52, 2.20), which did not show a significant difference. Secondary outcomes presented mixed results: rates of corticosteroid withdrawal at the end of follow-up (OR: 2.89; 95% CI: 1.69, 4.94) showed a significant difference, CBR duration off prednisolone (MD: -9.97; 95% CI: -39.88, 19.94) did not show a significant difference, stopping or changing treatment due to insufficient response or intolerance (OR: 0.09; 95% CI: 0.02, 0.46) showed a significant difference, and cumulative prednisolone dose (MD: -4.33; 95% CI: -15.24, 6.57) did not show a significant difference. Adverse events included gastrointestinal symptoms (OR: 0.48; 95% CI: 0.28, 0.82), which showed a significant difference, infections, leukopenia, elevated liver enzymes, rash, and fatigue, none of which showed significant differences.

Discussion: This meta-analysis shows that MMF showed significant benefits in reducing No Response rates and improving corticosteroid withdrawal outcomes, with a better adverse event profile, particularly in gastrointestinal symptoms. These findings support considering MMF as a first-line treatment option for AIH, warranting further research and broader clinical evaluations to optimize treatment strategies.



Disclosures:


Muhammad Tayyab Anwar, MD¹, Muhammad Shahzil, MD², Muhammad Ali Khaqan, MD¹, Edzel Lorraine Co, MD³, Alejandro J. Nieto Dominguez, MD¹, Sibgha Farooq, MBBS⁴, Maryam Kausar Nawaz, MBBS⁵, Rameez Akram Tarar, MD⁶, Hamza Naeem, MD⁶, Muhammad Bilal Ibrahim, MD¹, Anzal Abdullah, ⁴. P4638 - Comparative Efficacy of Mycophenolate Mofetil vs Azathioprine as First-Line Treatments for Autoimmune Hepatitis in Treatment Naive Patients: A Meta-Analysis, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.